www.gavi.org

How does Gavi make vaccine investment decisions?

Judith Kallenberg

Global Vaccine and Immunization Research ForumJohannesburg, South-Africa, 16 March 2016

Vaccine Investment Strategy (VIS)

Evidence-based approach to identifying potential new

vaccine priorities for Gavi support

• Evidence review, analyses, stakeholder consultations, independent

expert advice

• Once every five years, aligned with strategic cycle

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All existing commitments maintained

Implementation of VIS recommendations depends on

• available resources

• vaccine development outcomes

• WHO normative guidance

• country demand

Gavi-supported vaccines

Refers to the first Gavi-supported introduction of each vaccine.

1 Contribution towards a cholera vaccine stockpile 2014-2018; 2 New support for additional yellow fever vaccination campaigns

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Malaria

Rabies MaternalInfluenza

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Dengue

RSV

Cholera

Rubella

HPV

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VIS process: 5 steps

1. WHO ‘landscape analysis’ of vaccines in scope: anticipated licensure

within next 5 years

2. Development of prioritisation criteria through Gavi stakeholder

consultations: impact, cost, implementation feasibility

2013 criteria:

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Impact Additional impact

considerationsImplementation

feasibilityCost and value

for money

Child mortality Epidemic potential Capacity and supplierbase

Vaccine procurement cost

Overall mortality Global or regional public health priority

Gavi market shaping potential

In-country operationalcost

Overall morbidity Herd immunityEase of supply chain integration

Procurement cost per event averted

Availability of alternative interventions

Ease of programmatic integration

Socio-economic inequityVaccine efficacy and safety

Gender inequity

Disease of regional importance

VIS process: 5 steps

1. WHO ‘landscape analysis’ of vaccines in scope: anticipated licensure

within next 5 years

2. Development of prioritisation criteria through Gavi stakeholder

consultations: impact, cost, implementation feasibility

3. Assessment of vaccines against criteria based on demand/cost

projections, market analysis, etc.

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Methodology for vaccine evaluation

1. Identify vaccination scenarios

2. Develop demand forecast

4. Develop cost estimates

3. Develop impact estimates

5. Assess other disease/vaccine features

Methodology for vaccine prioritisation

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6. Populate scorecards

• Health impact

• Cost

• Implementation feasibility

• Other considerations

7. Compare vaccines against selected criteria

VIS process: 5 steps

1. WHO ‘landscape analysis’ of vaccines in scope: anticipated licensure

within next 5 years

2. Development of prioritisation criteria through Gavi stakeholder

consultations: impact, cost, implementation feasibility

3. Assessment of vaccines against criteria based on demand/cost

projections, market analysis, etc.

4. Development vaccine shortlist based on relative comparisons

5. In-depth analysis and consultations, and comparison with current portfolio � vaccine investment recommendations

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Gavi vaccine investment decisions

2008 VIS:

• Portfolio decisions: HPV, rubella, JE

• Typhoid conjugate pending

2013 VIS:

• Expanded support for yellow fever campaigns

• Time-limited contribution to global cholera stockpile

• Learning agenda: rabies and cholera studies to fill evidence gaps

• Malaria vaccine support to be re-assessed following trials

Other vaccine investment decisions:

• IPV, measles, Ebola

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Lessons learned

� Varied data availability and data quality a challenge for

comparisons

� Uncertainty of projections for pipeline vaccines, e.g.

Typhoid

� Critical and persistent evidence gaps for ‘neglected’

vaccines’, e.g. rabies

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Looking forward to VIS 2018 (1/2)

Scope – preliminary view (TBC)

• For re-assessment: dengue, Oral Cholera Vaccine, (maternal)

influenza, rabies PEP, meningococcal multivalent, Hepatitis E, DTP

booster, Hepatitis B birth dose

• New: RSV, Group B Streptococcus, norovirus, …?

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Looking forward to VIS 2018 (2/2)

Strategic and epidemiological shifts

• Coverage and equity goals in 2016-2020 Gavi strategy

• Emerging infectious diseases and increased focus on outbreak

preparedness and response

Changing vaccine profiles and funding rationales

• Special target groups (geographies, populations)

• Maternal vaccines: influenza, Tetanus Toxoid, pertussis, GBS, RSV

• Morbidity vs mortality

• Broad rollout vs. smaller catalytic investments (e.g. pilots)

• Health impact vs preparedness: influenza, OCV, mening, Zika, …?

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www.gavi.org

THANK YOU

Category VIS Criteria Phase I Indicator

Healthimpact

Impact on child mortalityU5 future deaths averted, 2015 – 2030

U5 future deaths averted per 100,000 vaccinated population

Impact on overall mortalityTotal future deaths averted, 2015 – 2030

Total future deaths averted per 100,000 vaccinated population

Impact on overall morbidity

Total future cases averted, 2015 - 2030

Total future cases averted per 100,000 vaccinated population

Long-term sequelae

Additionalimpactconsid-erations

Epidemic potential Epidemic potential of disease

Global or regional public health priority Presence of global / regional (UN) resolution on elimination or eradication

Herd immunity Herd immunity threshold

Availability of alternative interventions Current use of alternative interventions for effective disease control (prevention and treatment) and potential for scale up

Socio-economic inequity Disproportionate impact on poor

Gender inequity Disproportionate impact on one gender

Disease of regional importance Burden concentrated in a subset of GAVI countries within the same region

Implement-ation

feasibility

Capacity and supplier base Capacity to meet GAVI demand and # of manufacturers by 2020

GAVI market shaping potential GAVI demand (by volume) as % of global demand

Ease of supply chain integration Packed volume (cm3)

Ease of programmatic integrationAlignment with other vaccine schedules and significant change in health worker practices/behavior required

Vaccine efficacy and safety Vaccine efficacy (as defined by clinical endpoints) and safety

Cost and value for money

Vaccine procurement cost1 Total procurement cost to GAVI and countries, 2015 - 2030

In-country operational cost Incremental in-country operational costs per vaccinated person

Procurement cost per event averted2 Procurement cost per death / case averted

Evaluation criteria and indicators (VIS 2013)

1. Procurement cost includes vaccine, syringe, safety box, and freight 2. Scoring based on cost per future death averted